RESEARCH
OPEN ACCESS
For numbered affiliations see end of
article.
Correspondence to: M J Drake School of
Surgery and Cancer, Urology Department
3N, Charing Cross Hospital, London, UK
mjdrake@imperial.ac.uk
https://orcid.org/0000-0002-6230-2552
Additional material is published online
only. To view please visit the journal
online
Cite this as: BMJ 2023;383:e075219
http://dx.doi.org/10.1136/bmj-2023-075219
Accepted: 02 October 2023
the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
Treatment of lower urinary tract symptoms in men in primary care
using a conservative intervention: cluster randomised controlled trial
Marcus J Drake, 1 Jo Worthington, 2 Jessica Frost, 2 Emily Sanderson, 2 Madeleine Cochrane, 2 Nikki Cotterill, 3
Mandy Fader, 4 Lucy McGeagh, 5 Hashim Hashim, 6 Margaret Macaulay, 4 Jonathan Rees, 7 Luke A Robles, 8
Gordon Taylor, 9 Jodi Taylor, 2 Matthew J Ridd, 10 Stephanie J MacNeill, 2 Sian Noble, 11 J Athene Lane2
ABSTRACT
OBJECTIVE
To determine whether a standardised and manualised
care intervention in men in primary care could achieve
superior improvement of lower urinary tract symptoms
(LUTS) compared with usual care.
DESIGN
Cluster randomised controlled trial.
SETTING
30 National Health Service general practice sites in
England.
PARTICIPANTS
Sites were randomised 1:1 to the intervention and
control arms. 1077 men (≥18 years) with bothersome
LUTS recruited between June 2018 and August 2019:
524 were assigned to the intervention arm (n=17
sites) and 553 were assigned to the usual care arm
(n=13 sites).
INTERVENTION
Standardised information booklet developed with
patient and expert input, providing guidance on
conservative and lifestyle interventions for LUTS in
men. After assessment of urinary symptoms
(manualised element), general practice nurses and
healthcare assistants or research nurses directed
participants to relevant sections of the manual and
provided contact over 12 weeks to assist with
adherence.
MAIN OUTCOME MEASURES
The primary outcome was patient reported
International Prostate Symptom Score (IPSS)
measured 12 months after participants had consented
to take part in the study. The target reduction of 2.0
points on which the study was powered reflects the
minimal clinically important difference where
baseline IPSS is <20. Secondary outcomes were
patient reported quality of life, urinary symptoms and
perception of LUTS, hospital referrals, and adverse
events. The primary intention-to-treat analysis
included 887 participants (82% of those recruited)
and used a mixed effects multilevel linear regression
model adjusted for site level variables used in the
randomisation and baseline scores.
RESULTS
Participants in the intervention arm had a lower mean
IPSS at 12 months (adjusted mean difference −1.81
points, 95% confidence interval −2.66 to −0.95)
indicating less severe urinary symptoms than those
in the usual care arm. LUTS specific quality of life,
incontinence, and perception of LUTS also improved
more in the intervention arm than usual care arm at
12 months. The proportion of urology referrals
(intervention 7.3%, usual care 7.9%) and adverse
events (intervention seven events, usual care eight
events) were comparable between the arms.
CONCLUSIONS
A standardised and manualised intervention in
primary care showed a sustained reduction in LUTS
in men at 12 months. The mean difference of −1.81
points (95% confidence interval −0.95 to −2.66) on
the IPSS was less than the predefined target
reduction of 2.0 points.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN11669964.
Introduction
Lower urinary tract symptoms (LUTS) relate to the
storage and voiding of urine (box 1). The severity and
prevalence of LUTS in men increases with age (as
much as 30% in men older than 65 years),1 with
greater numbers likely to be affected as the
population ages. LUTS can have a substantial impact
on quality of life,2 with problematic LUTS referred to
as bothersome. Men usually present with a range of
LUTS that can relate to storage, voiding, or
post-voiding urinary symptoms, and most men are
initially assessed and managed by their general
practitioner. LUTS in men can be caused by
obstruction of the prostate or bladder dysfunction,
or both, but symptoms can also be influenced by
lifestyle factors. The UK National Institute for Health
and Care Excellence and the European Association
of Urology recommend assessments to exclude
serious medical conditions and to categorise and
assess the impact of precise symptoms.1 3 Assessment
of LUTS is time consuming, however, and the level
undertaken in general practice varies.4
Box 1: Lower urinary tract symptoms in men
Lower urinary tract symptoms (LUTS) in men can be
caused by structural or functional abnormalities of the
bladder, prostate gland, or urethra
Voiding LUTS are problems passing urine, such as
hesitancy, slow urinary stream, and dribbling
Storage LUTS include urgency, increased urinary
frequency, and nocturia. Storage LUTS can be due to
increased urine volumes from high fluid intake or
systemic conditions (cardiovascular, respiratory, renal,
or endocrine)
Patients may experience one or more LUTS, and the
severity of each symptom may not correlate with how
much patients consider the symptoms to be bothersome
LUTS can be measured using the International Prostate
Symptom Score (IPSS), with scores of 0-7 categorised as
mild overall severity, 8-19 as moderate, and 20-35 as
severe
1
 RESEARCH
NICE and the European Association of Urology recommend using
conservative treatments for LUTS initially, including bladder
training, advice on fluid intake, and lifestyle advice, although
evidence on effectiveness of these measures is lacking.1 5An NHS
Evidence Update in 2012 indicated a role for self-management to
treat LUTS, based on a post hoc analysis of a single centre
randomised controlled trial of 140 men.6 -8 NICE Clinical Guideline
97, however, recommends that a multicentre randomised controlled
trial would be needed to determine effectiveness in clinical practice.1
Delivery of conservative treatments in primary care is also limited,4
which can result in men simply receiving drugs to treat prostate
conditions, potentially being referred inappropriately to secondary
care, or enduring persistent bothersome symptoms.
As provision for LUTS in men in primary care is inconsistent, primary
care health professionals require practical resources to support the
assessment of urinary symptoms and to enhance patient engagement
with conservative management interventions. We aimed to address
this need in the Treating Urinary Symptoms in Men in Primary
Healthcare (TRIUMPH) study. The main objective was to determine
whether a standardised and manualised care intervention in men
in primary care in the UK could achieve superior improvement of
LUTS compared with usual care. The primary outcome was overall
International Prostate Symptom Score (IPSS) measured 12 months
after participants had consented to participate in the study.
Methods
The TRIUMPH study was a multicentre, pragmatic, two arm cluster
randomised controlled trial in UK primary care. The trial was
conducted in 30 general practice sites, with participants recruited
from June 2018 to August 2019. The trial design included an internal
pilot recruitment phase of four months’ duration, primarily to verify
that recruitment was achievable before progression to the main
phase of the trial. Specification of an exact figure for the number of
eligible participants required by general practices to take part in
the trial, as determined by a pre-randomisation practice database
search, was removed for the main phase of the trial to allow
flexibility according to patients’ response rates.
The trial protocol was submitted for publication before recruitment
ended, and the trial was registered prospectively on 12 April 2018.9
The statistical analysis plan was finalised in July 2020, before
completion of follow-up (August 2020).10
General practice sites
Clinical Research Networks recruited the general practices from
across the National Institute for Health Research (NIHR, now referred
to as the National Institute for Health and Care Research) West of
England and Wessex Clinical Research Network regions. Practices
were eligible if they had an adequate number of eligible patients
determined by a pre-randomisation practice database search (to
achieve a target recruitment of 35 participants at each site), with
suitable space for treatment rooms and availability for training of
healthcare professionals and baseline visits. In the final selection
of practices for randomisation, we also considered representative
practice list size, social deprivation score (index of multiple
deprivation determined using the general practice’s postcode), and
preference for how the intervention would be delivered (practice
staff or trial research nurses) if the practice was randomised to the
intervention arm.9 Groups of practices with shared nurse resources
were randomised as a single site.
Participants
Men aged 18 years or older who had presented to primary care with
LUTS within the past five years according to general practice records
2 the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
and were currently experiencing at least one bothersome LUTS were
potentially eligible for the study. Men were excluded if they lacked
capacity to consent, were unable to pass urine without a catheter
(indwelling or intermittent catheterisation), had a relevant
neurological disease or referral, were undergoing urological testing
for LUTS, were being treated for prostate or bladder cancer, had
undergone prostate surgery, had poorly controlled diabetes mellitus,
were recently referred or currently under urology review, had visible
haematuria, or were unable to complete trial assessments in English.
The general practices conducted a single database search designed
specifically for the trial to identify potentially eligible patients, and
the general practitioners manually verified the findings using
electronic medical records. To avoid any bias in patient selection,
each site conducted a single mail out to potentially eligible patients
before notification of its randomisation status. While masked to the
allocation of the practice and to avoid bias, NIHR Clinical Research
Network nurses or clinical practitioners trained by the trial team
telephoned patients expressing an interest in taking part in the
study. Calls were conducted to confirm eligibility, particularly the
subjective criterion of whether LUTS were currently bothersome to
the patient, as initial screening by the general practices only
identified men coded with LUTS within the preceding five years.
The telephone calls also ensured that patients understood the study,
answered any questions, and confirmed their willingness to
participate in the study.
Patients deemed willing and eligible completed a postal consent
form and questionnaire containing baseline measures. All patients
received the same consent form and questionnaires, but those in
the intervention arm also received a bladder diary to be completed
before their face-to-face visit for assessment of symptoms.
Participants remained blinded to their treatment arm while
completing baseline measures and were not aware that completion
of the bladder diary indicated randomisation to the intervention
arm. Participants assigned to receive the intervention did not have
sight of the booklet until after consent had been obtained, and
participants assigned to receive usual care remained unaware of
the content of the booklet throughout the trial.
Intervention
The TRIUMPH intervention employed a standardised information
booklet. Participants were directed to information within the booklet
that was applicable to them via healthcare professional assessment
and discussion, providing the manualised element of the
intervention. In collaboration with patients, healthcare
professionals, and health psychologists, the booklet was developed
for the study from patient information sheets produced by the British
Association of Urological Surgeons (see supplementary file). The
booklet provides targeted guidance on conservative and lifestyle
interventions for LUTS in men and is water resistant and able to lie
flat for ease of use when opened. Sections are tabbed and colour
coded for specific LUTS symptoms and advice.
Depending on site preference, participants received the booklet
from a general practice clinical nurse, research nurse, healthcare
assistant, or trial research nurse. The trial research nurses provided
training and ongoing support to the healthcare professionals
delivering the intervention. Before the participants attended for an
intervention visit, the healthcare professional reviewed the
participants’ baseline urinary symptoms, utilising their completed
IPSS, International Consultation on Incontinence Questionnaire
Urinary Incontinence-Short Form, and International Consultation
on Incontinence Questionnaire bladder diary. During this visit the
healthcare professional discussed the participants’ individual

symptoms and how bothersome they were to the participant. The
healthcare professionals were provided with decision tools (see
supplementary file) enabling them to direct participants to relevant
sections of the booklet on the basis of reported symptoms. A
maximum of three sections were recommended to each participant
and tabbed with discreet stickers. The sections provided advice on
drinks and liquid intake, controlling an urgent need to urinate,
exercises for the pelvic floor muscles to help stop bladder leakage,
emptying the bladder as completely as possible, getting rid of the
last drops of urine, and reducing sleep disturbance caused by the
need to urinate at nighttime.
To encourage and gauge adherence to the intervention, healthcare
professionals followed-up the participants by telephone at one week
and then by telephone, email, or text at four and 12 weeks, according
to the participants’ preference. Participants retained the intervention
booklet thereafter. Participants in the intervention arm continued
to receive usual care for LUTS from their doctor.
The usual care practices were requested to continue standard local
management for LUTS. At the end of the study, participants in the
usual care arm were provided with the booklet along with a
summary of the trial’s results.
Participants in both randomised groups were provided with progress
updates of the study at three and nine months via a newsletter to
maintain engagement with the trial and encourage completion of
follow-up questionnaires.
Outcomes
The primary outcome measure was the validated patient reported
IPSS at 12 months after consent to participate in the study—a score
that is extensively used in LUTS research and widely employed in
urology services.11 IPSS scores ranged from 0 to 35, with higher
scores indicating more severe symptoms. The endpoint of 12 months
was chosen to measure whether the effect of the TRIUMPH
intervention on LUTS was sustained after the initial 12 week delivery
period.
Secondary outcomes collected by questionnaire at baseline and six
and 12 months after consent comprised the IPSS quality of life (LUTS
related quality of life score, six and 12 months), the IPSS (overall
score for urinary symptoms, six months), the International
Consultation on Incontinence Questionnaire Urinary
Incontinence-Short Form symptoms score (six and 12 months,12
which supplements the IPSS with measurement of incontinence
and post-void dribble), the EQ-5D (five level version of the EuroQoL
index, EQ-5D-5L, measure of health status, six and 12 months, used
to create quality adjusted life years for the health economic
evaluation, which will be reported separately),13 and the Brief Illness
Perception Questionnaire (measuring participants’ cognitive and
emotional perception of their LUTS, and which was modified
slightly, with developers’ permission, to ask about “urinary
symptoms” rather than “illness,” six and 12 months).14
The number of LUTS related adverse events (prespecified as urinary
tract infections, catheterisations, urinary retention, prostatitis),
deaths, and the number of referrals to secondary care (urology) at
12 months post-consent were extracted from primary care electronic
medical records through trial specific automated database searches.
These searches were conducted a minimum of one month after the
final participant for each site had completed follow-up. The sites
provided the central trial team with anonymised data extracts for
analysis.
Case report forms were specifically designed for this study.
Healthcare professionals completed the forms for the intervention
the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
RESEARCH
arm only—at the intervention visit and during the 12 week treatment
phase to collect details on sections of the booklet recommended to
participants, and feedback on the booklet.
Sample size calculation
TRIUMPH was designed to detect a mean difference of 2.0 points
between arms on the IPSS at 12 months post-randomisation with
90% power, as this is the mean decrease in IPSS among men who
rate their condition as slightly improved when the baseline scores
are <20 points.15 As outlined in the study protocol,9 this value is
less than the previously observed minimal clinically important
difference of 3 points for IPSS16 but allows for a difference in just
one symptom. Based on a scoping search of local general practices,
we estimated we would need a mean cluster size of 35 participants
and proposed an estimated intraclass correlation coefficient of 0.05
based on other studies in primary care.17 The experience of previous
trials centres suggested it would be prudent to allow for up to 30%
loss to follow-up. On this basis, we estimated that 840 participants
would be needed from at least 24 sites to achieve 90% power.
Early in the study, however, we observed variability between sites
in the number of participants recruited, thus necessitating a revision
of the sample size calculation. Using recruitment data available at
the time, we estimated that the mean number of participants who
would need to provide consent at each site would be 26 and that
the coefficient of variation of the mean cluster size would be 0.26.
Ignoring clustering and loss to follow-up, we determined that 263
participants in total would be required to detect a difference of 2
units in IPSS with 90% power assuming a common standard
deviation of 5. Our updated design effect assumed an intraclass
correlation coefficient of 0.05; a mean of 26 patients consenting in
each site but only 70% providing primary outcome data resulting
in a mean cluster size of 18.2; and a 0.26 coefficient of variation in
cluster sizes. Under these revised assumptions, the design effect is
1.92, meaning that 506 participants in total would be required to
provide primary outcome data. Given our assumed loss to follow-up,
724 patients needed to provide consent to participate in the study,
and as each site was expected to obtain consent for 26 patients, this
translated to 28 sites in total. Allowing for some practices not to
perform as expected, 30 were ultimately recruited in agreement
with the trial management group, steering committee, and funder.
Randomisation and blinding
General practice sites were the units of allocation. A statistician
blinded to the identity of practices randomised them on a 1:1 basis
to deliver either the TRIUMPH intervention or usual care.
Randomisation was performed after the practices had completed
screening of patients and sent out invitations to eligible participants.
Randomisation was minimised by centre (West of England and
Wessex Clinical Research Network regions), practice size (number
of registered patients), and area level deprivation of the practice
(index of multiple deprivation score). We incorporated a random
element into the minimisation procedure such that there was a 40%
probability that allocation was random, with a 50-50 chance of
practices being allocated to either arm. Area level deprivation
assessed at the lower super output area level (geography comprising
between 400 and 1200 households) can estimate deprivation for
individuals (using home postcodes to identify the lower super output
area level), but middle layer super output area level (geography
made up of four or five lower super output area level) data better
reflect the area level deprivation of general practices because the
catchment area of a general practice is generally wider than the
area covered by the lower super output area level.18 As such, we
mapped the postcodes of the general practices onto lower super
3
 RESEARCH
output area level then middle layer super output area level.
Population averaged index of multiple deprivation scores (2015)
were then calculated based on the scores of lower super output area
level within each middle layer super output area level.
To minimise selection and recruitment bias, staff who conducted
telephone calls for patient eligibility were blinded to practice
allocation. Participants were blinded to their allocation until they
had completed the baseline questionnaire and provided a signed
consent form.
Safety
General practices were responsible for reporting serious adverse
events experienced by the participants; and participants were also
asked to report any inpatient stays in their follow-up questionnaires,
which would prompt review by their general practitioner. The study
independent data monitoring committee reviewed reported serious
adverse events every six months. All other adverse events were
collected from participants’ primary care electronic medical records,
as part of the secondary outcomes.
Statistical analysis
Statistical analyses were conducted with all consenting participants
retained in the randomised arm of their general practice. Baseline
characteristics at individual and practice level were summarised
using means, standard deviations, medians (interquartile ranges),
or number (percentage) depending on the nature and distribution
of the data.
The primary analysis of IPSS at 12 months was conducted on a
modified intention-to-treat (ITT) basis, and comparisons between
treatment arms were made using mixed effect multilevel linear
models (individuals (level 1) nested within general practices (level
2)) adjusting for individual level baseline IPSS and practice level
variables used in the randomisation based on those providing
non-missing data for the variables included in the model. The results
are presented as the mean difference between arms, 95% confidence
interval, P value, and model intraclass correlation (95% confidence
interval).
The secondary outcomes were also analysed on a modified ITT basis.
IPSS at six months were analysed using a mixed effect multilevel
linear model (individuals (level 1) nested within general practices
(level 2)) adjusting for individual level baseline IPSS and practice
level variables used in the randomisation. Additionally, and
separately, a repeated measures analysis was conducted using a
repeated measures linear mixed model (IPSS at six and 12 months
(level 1), nested within participants (level 2) and nested within
general practices (level 3)) adjusting for individual level baseline
IPSS scores and practice level variables used in the randomisation.
Minimal clinically important differences for LUTS in men are not
established in the literature for the secondary outcomes included.
We planned seven sensitivity analyses to assess the robustness of
the primary analysis to varying assumptions. Each of these
sensitivity analyses was compared with the primary analysis.
• Descriptive statistics were used to assess whether baseline
characteristics were balanced between the two arms, and, if
differences were observed, the primary analysis would be re-run
adjusting for those imbalanced variables. This analysis was not
performed, however, because we found no evidence of imbalance
in variables not already included in the primary analysis.
• To allow for possible clustering of outcomes within nurses and
healthcare assistants delivering the intervention, we grouped patient
level data according to the combination of practice and nurse or
4 the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
healthcare assistant delivering the intervention. The primary
analysis was then re-run using a single random effect for this level
of clustering.
• Although the target recruitment was reached before the covid-19
outbreak, we wanted to allow for any influence of the outbreak and
subsequent lockdowns on participation and symptom reporting.
To do this we repeated the primary analysis including a binary
variable for whether or not the outcome measure was taken before
or after 11 March 2020 (the date the World Health Organization
declared the outbreak a pandemic).
• A small number of recruited participants were subsequently found
to be ineligible. They were included in the primary analysis, and a
sensitivity analysis was performed excluding those individuals.
• A series of per protocol analyses were performed using different
definitions of protocol compliance (see supplementary table S2).
• Recognising the biases inherent in per protocol analyses we also
performed a complier average causal analysis. Compliers were those
participants who received the intervention booklet by the time of
follow-up for the primary outcome. The estimates for complier
average causal analysis were obtained using instrumental variable
regression with the same variables used in the primary analysis,
with the randomised arm as the instrumental variable and an
indicator variable for compliance.
• We explored the impact of missing primary outcome data using
different assumptions for missingness: “best” and “worst” case
scenarios as well as multiple imputation by chained equations to
impute missing data.
To explore whether the effectiveness of the intervention on the
primary outcome differed by participant subgroup, we performed
four prespecified subgroup analyses. In each case, effect
modification was assessed by including a subgroup-treatment
interaction term and performing a likelihood ratio test comparing
the model with and without the interaction term. A significance
level of 5% was used, but as these analyses were not statistically
powered, they should be interpreted with caution. Subgroup
analyses assessed whether effectiveness differed by the nature of
LUTS at baseline measured by the ratio of the IPSS voiding score to
the storage score; whether a practice nurse, healthcare assistant,
or trial nurse delivered the intervention; the participant’s preferred
method of contact at baseline; and the number of contacts between
the nurse or healthcare assistant and participant at intervention
practices.
Patient and public involvement
Patient and public involvement (PPI) representatives have been
involved at all stages from a patient co-applicant at the grant
application stage to help shape the project to patient representative
members of our trial management group and trial steering committee
who helped steer the trial. Wider patient advisory group meetings
were also held over the course of the study. Development of the
TRIUMPH intervention booklet was one of the key roles for PPI,
resulting in important changes to aid clarity and usability and
recommendations on what patients would consider a manageable
level of advice to follow. PPI review of our patient-facing study
materials was also undertaken, including patient questionnaires
to assess clarity and participant burden, newsletters, and the study
website. Further PPI involvement has included discussion of some
of our initial qualitative findings related to men’s experiences of
the patient pathways for LUTS within the NHS, as well as routes for
implementation and dissemination, and patients will continue to
be involved.
 RESEARCH

Results patients (mean=19 576) reflecting some of the larger practices in

the Wessex and West of England regions (combined regional median
Thirty primary care sites (32 general practices; one group of three
practice size in June 2019: 9440). Area level index of multiple
practices were randomised as a single site) were recruited and all
deprivation scores ranged from 4.22 to 33.62 for practices, and the
contributed to the intention-to-treat analysis (fig 1 and fig 2); 17
mean was slightly higher in usual care practices, suggesting greater
were randomised to the intervention and 13 to usual care. At the
levels of socioeconomic deprivation than in intervention practices
time of recruitment, the general practices provided estimated
(table 1).
(pre-screening) practice list sizes ranging from 7600 to 48 623

the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219 5

 RESEARCH

Fig 1 | Flow of practice sites and participants through study. *See supplementary table S1 for reasons for exclusion. EOI=expression of interest; GP=general practitioner;
LUTS=lower urinary tract symptoms

6 the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219

 RESEARCH

Fig 2 | Flow of practice sites and participants through study as continuation of figure 1. †Participants remained blinded to treatment arm through all screening processes,
until point of consent. CRN=clinical research network; EOI=expression of interest; IPSS=International Prostate Symptom Score

the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219 7

 RESEARCH

Table 1 | Characteristics of practice sites and participants at baseline by intervention group. Values are number (percentage) unless stated otherwise
Intervention arm Usual care arm
No* Estimate No* Estimate
Site level characteristics
Total No of sites 17 — 13 —
Mean (SD) practice size 17 20 694 (9714) 13 18 114 (7998)
Mean (SD) No of participants 17 31 (12.05) 13 43 (12.71)
providing consent per site
Mean (SD) area level 17 11 (5.02) 13 16 (8.39)
deprivation of practice based
on postcode
Participant level characteristics
Total No of participants 524 — 553 —
Personal characteristics
Mean (SD) age (years); 524 68.9 (9.3) (32-94) 553 68.4 (9.2) (30-95)
(min-max)
Ethnicity:
White 522 513 (98.3) 550 542 (98.6)
Black, Asian, mixed, or other 8 (1.5) 5 (0.9)
Disclosure declined 1 (0.2) 3 (0.6)
Marital status:
Single 517 21 (4.1) 543 25 (4.6)
Married or civil partnered 436 (84.3) 455 (83.8)
Divorced 31 (6.0) 32 (5.9)
Widowed 27 (5.2) 28 (5.2)
Disclosure declined 2 (0.4) 3 (0.6)
Index of multiple deprivation
fifth:
1st (most deprived) 506 17 (3.4) 525 21 (4.0)
2nd 33 (6.5) 37 (7.0)
3rd 67 (13.2) 106 (20.2)
4th 141 (27.9) 136 (25.9)
5th (least deprived) 248 (49.0) 225 (42.9)
Median (IQR) index of multiple 8.80 (5.75-13.71) 9.89 (6.21-15.45)
deprivation score
Clinical characteristics
Mean (SD) height (cm) 518 176.72 (6.77) (152.40-198.12) 550 176.93 (7.41) (157.48-208.28)
(min-max)
Mean (SD) weight (kg) 510 83.36 (14.45) (55.02-152.41) 549 83.89 (14.29) (53.98-136.98)
(min-max)
Mean (SD) body mass index 508 26.71 (4.40) (18.91-52.31) 549 26.76 (4.00) (17.57-42.18)
(min-max)
No of comorbidities:
0 478 151 (31.6) 544 171 (31.4)
1 160 (33.5) 197 (36.2)
>1 167 (34.9) 176 (32.3)
Test results in 6 months
pre-baseline:
Urine analysis: abnormal 79 1 (1.3) 52 2 (3.9)
Kidney function: eGFR 170 — 215 —
(mL/min/1.73m2)
eGFR measures:
Mean (SD) eGFR 170 73.5 (15.7) 215 74.6 (13.2)
Median (IQR) eGFR 76.5 (65-87) 75 (66-87)
Min-max eGFR 28-98 36-100
CKD stages based on recent
eGFR (mL/min/1.73m2):

8 the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219

 RESEARCH

Table 1 | Characteristics of practice sites and participants at baseline by intervention group. Values are number (percentage) unless stated otherwise
(Continued)

Intervention arm Usual care arm

No* Estimate No* Estimate
≥90: normal 170 28 (16.5) 215 33 (15.4)
90-60: stages G1-G2 114 (67.1) 154 (71.6)
30-59: stage G3 27 (15.9) 28 (13.0)
<30: stages G4-G5 1 (0.6) 0 (0)
No of GP consultations in 12
months before baseline:
Mean (SD) 478 4.4 (3.7) 544 4.8 (5.0)
Median (IQR) 4 (2-6) 4 (2-6)
Min-max 0-23 0-58
Referrals to urology in 12
months pre-baseline:
0 478 464 (97.1) 544 525 (96.5)
1 14 (2.9) 19 (3.5)
>1 0 0
Patient reported symptoms and quality of life
Mean (SD) IPSS (min-max):
Incomplete emptying 512 1.7 (1.5) (0-5) 549 1.9 (1.5) (0-5)
Frequency 514 2.7 (1.3) (0-5) 551 2.9 (1.4) (0-5)
Intermittency 514 1.9 (1.6) (0-5) 549 2.0 (1.7) (0-5)
Urgency 513 2.1 (1.6) (0-5) 549 2.3 (1.7) (0-5)
Weak stream 510 1.9 (1.5) (0-5) 549 2.0 (1.7) (0-5)
Straining 513 0.8 (1.2) (0-5) 548 1.0 (1.3) (0-5)
Nocturia 516 2.6 (1.4) (0-5) 551 2.4 (1.2) (0-5)
Mean (SD) total IPSS 501 13.6 (5.8) (1-33) 541 14.6 (6.6) (2-34)
(min-max)
Symptom severity by IPSS:
≤7: mild 501 76 (15.2) 541 74 (13.7)
8-19; moderate 342 (68.3) 338 (62.5)
≥20: severe 83 (16.6) 129 (23.8)
Mean (SD) IPSS quality of life 516 3.5 (1.2) (0-6) 551 3.6 (1.1) (0-6)
score† (min-max)
Mean (SD) ICIQ-UI-SF total 513 3.6 (3.6) (0-14) 542 3.9 (3.7) (0-15)
score (min-max)
ICIQ-UI-SF urine leakage‡:
Never 523 185 (35.4) 553 161 (29.2)
Before getting to the toilet 205 (39.2) 237 (42.9)
When coughing/sneezing 24 (4.6) 24 (4.4)
When asleep 12 (2.3) 15 (2.7)
During physical activity 23 (4.4) 27 (4.9)
After urinating/when dressed 175 (33.5) 205 (37.1)
No obvious reason 36 (6.9) 42 (7.6)
All the time 1 (0.2) 1 (0.2)
Mean (SD) B-IPQ total score 440 38.7 (11.0) (1-75) 478 39.4 (10.4) (6-72)
(min-max)
Bladder diary§:
Incontinence 502 100 (19.9) — —
Urgency 507 364 (71.8) — —

the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219 9

 RESEARCH

Table 1 | Characteristics of practice sites and participants at baseline by intervention group. Values are number (percentage) unless stated otherwise
(Continued)

Intervention arm Usual care arm

No* Estimate No* Estimate
Nocturia¶ 261 222 (85.1) — —
B-IPQ=Brief Illness Perception Questionnaire; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; IQR=interquartile range; ICIQ-UI-SF=International Consultation on Incontinence
Questionnaire Urinary Incontinence-Short Form; IPSS=International Prostate Symptom Score; SD=standard deviation.

* Number providing non-missing data at baseline.

† Question asked: “If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?”
‡ Question asked: “When does urine leak?”
§ Bladder diary completed as part of initial assessment in intervention arm only.
¶ For description purposes at baseline, nocturia is defined as waking to urinate at least once on two nights or to urinate twice or more. When data on waking or sleeping were not provided by participants, the variable was
set to missing.

The general practices identified 7872 potentially eligible patients
from database searches. A random selection of 160 patients were
not screened owing to agreed limits on screening numbers by large
practices, and 97 patients were not screened owing to practice
capacity. Of the remaining 7615 patients manually screened by their
doctors, 2047 were ineligible (fig 1) (see supplementary table S1).
Of the eligible patients identified, 4808 were invited to join the
study, with a maximum of 150 (pilot phase) or 220 (main phase)
invited patients per site, to avoid over-representation of larger sites.
Of the 4808 participants invited, 2300 (47.8%) responded to the
single invitation (no reminders were sent out). Of those who
responded, 1671 were interested in taking part (72.6%). On further
screening for eligibility (in particular for current bothersome LUTS),
1293 (77.4%) of those interested were eligible. Of these, 524
participants were recruited from intervention sites and 553 from
usual care sites (83% of those interested and eligible) (fig 2). Patients
remained blinded to their assignment arm until after consent had
been obtained. On average, men were in their late 60s, with a
predominance of white and married or civil partnered men (table
1). The distribution of clinical characteristics was comparable
between treatment arms. The median number of doctor
consultations in the 12 months before baseline was the same in both
arms, but the proportion with a referral to urological services in
that period was slightly lower in the intervention arm (intervention
2.9%, usual care 3.5%). Baseline IPSS was slightly lower in the
intervention arm than usual care arm, indicating a lower symptom
burden; but this was not reflected in the International Consultation
on Incontinence Questionnaire Urinary Incontinence-Short Form
focused on incontinence. Quality of life (IPSS quality of life) was
comparable between the two arms, as was patients’ perception of
their LUTS (measured using the Brief Illness Perception
Questionnaire).
Primary outcome: IPSS at 12 months
Overall, 915 participants (85.0% of those randomised) provided
primary outcome data, of whom 887 provided sufficient baseline
data to be included in the analysis. Some improvement in LUTS
occurred at 12 months in both arms, but this was greater in the
intervention arm (difference in IPSS −1.81 (95% confidence interval
−2.66 to −0.95), P<0.001) after adjustment for baseline values and
minimisation variables (table 2).

10 the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219

 RESEARCH

Table 2 | Analyses of treatment effectiveness on patient reported primary outcome and secondary outcomes
Intervention Usual care Adjusted analysis*
No† Mean (SD) No† Mean (SD) Difference (95% No analysed ICC (95% CI)
(min-max) (min-max) CI); P value
Primary outcome
IPSS: 12 months‡ 442 11.6 (6.2) (1-35) 473 13.9 (6.8) (0-32) −1.81 (−2.66 to 887 0.011 (0.001 to
−0.95); <0.001 0.086)
Secondary outcomes
IPSS (range 0-35):
6 months‡ 471 11.5 (6.1) (1-35) 501 13.8 (6.6) (1-32) −1.68 (−2.34 to 942 <0.001 (<0.001 to
−1.02); <0.001 <0.001)
6 and 12 months 913 11.6 (6.2) (1-35) 974 13.8 (6.7) (0-32) −1.70 (−2.35 to 1829 0.005 (0.0002 to
(repeated −1.05); <0.001 0.115)
measures
analysis)§
ICIQ-UI-SF score
(range 0-21):
6 months§ 476 3.6 (3.5) (0-15) 504 4.5 (4.1) (0-20) −0.53 (−1.02 to 961 0.022 (0.007 to
−0.04); 0.04 0.072)
12 months§ 453 3.7 (3.6) (0-18) 480 4.5 (4.1) (0-18) −0.74 (−1.15 to 915 <0.001 (<0.001 to
−0.33); <0.001 <0.001)
IPSS quality of life
score (range 0-6):
6 months‡ 483 3.0 (1.2) (0-6) 511 3.35 (1.25) (0-6) −0.29 (−0.43 to 984 NE
−0.15); <0.001
12 months‡ 463 2.9 (1.3) (0-6) 483 3.3 (1.25) (0-6) −0.34 (−0.50 to 937 0.004 (<0.001 to
−0.18); <0.001 0.274)
B-IPQ score (range
0-90):
6 months‡ 450 33.4 (11.9) (2-73) 430 38.3 (11.5) (1-76) −5.34 (−6.69 to 777 <0.001 (<0.001 to
−3.99); <0.001 <0.001)
12 months‡ 419 33.8 (12.0) (0-69) 427 38.4 (12.2) (0-71) −4.78 (−6.31 to 746 NE
−3.25); <0.001
B-IPQ=Brief Illness Perception Questionnaire; ICC=intraclass correlation; CI=confidence interval; ICIQ-UI-SF=International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form;
IPSS=International Prostate Symptom Score; NE=not estimable; SD=standard deviation.

Higher scores for IPSS, ICIQ-UI-SF, IPSS quality of life, and B-IPQ reflect more severe symptoms, greater impact on quality of life, or participants’ poorer perception of their LUTS.

* Adjusted for baseline scores and minimisation variables.

† Number of participants in each arm providing non-missing outcome data except in repeated measures analysis of IPSS (six and 12 months) where this reflects the number of repeated measures of IPSS in each arm.
‡ Analysed using mixed effect multilevel linear model (individuals (level 1) nested within general practices (level 2)) adjusting for individual level baseline outcome measure and practice level variables used in the randomisation.
§ Analysed using a repeated measures linear mixed model (IPSS at six and 12 months (level 1), nested within participants (level 2) and nested within general practices (level 3)) adjusting for individual level baseline IPSS
and practice level variables used in the randomisation.

A planned sensitivity analysis accounting for clustering by nurse
or healthcare assistant had little effect on the primary outcome
results (difference −1.79 (95% confidence interval −2.53 to −1.06),
P=0.004), nor did excluding three participants who were found to
be ineligible after follow-up began (difference −1.81 (−2.65 to −0.96),
P<0.001) or adjusting for whether the outcome data were collected
during the covid-19 pandemic (difference −1.89 (−2.69 to −1.09),
P<0.001). Imputation of missing data also yielded comparable results
to the complete case analysis (table 3).

Table 3 | Sensitivity analysis comparing results of ITT analysis of complete cases with ITT analyses, with missing IPSS data imputed
No imputed No used in analysis Overall mean (SD) Difference in means* P value
(95% CI)
Intervention arm Usual care arm
Complete case ITT 0 0 887 12.79 (6.64) −1.81 (−2.66 to −0.95) <0.001
Best case scenario 77 78 1042 10.89 (7.63) −1.89 (−2.89 to −0.88) <0.001
Worst case scenario 77 78 1042 14.82 (7.82) −1.14 (−2.08 to −0.20) 0.02
MICE† 82 80 1077 — −1.61 (−2.57 to −0.66) 0.001
CI=confidence interval; IPSS=International Prostate Symptom Score; SD=standard deviation ITT=intention to treat; MICE=multiple imputation by chained equations; SD=standard deviation.

* Analysis adjusted for baseline IPSS and minimisation variables.

† Data are imputed using IPSS at baseline and six months, treatment arm, practice size, centre, and deprivation (index of multiple deprivation). To allow for clustering in Stata, imputations were performed separately for
each practice.

the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219 11

 RESEARCH
Secondary outcomes
The difference in mean IPSS was also evident between the two arms
at six months, although slightly less than at 12 months, and in the
repeated measures analysis of IPSS (six and 12 months) (table 2).
Incontinence scores were also lower in the intervention arm
compared with usual care arm at six and 12 months (as assessed
with the International Consultation on Incontinence Questionnaire
Urinary Incontinence-Short Form), with the improvement in the
intervention arm being greater at 12 months than at six months
(table 2). Mean IPSS LUTS specific quality of life scores at six and
12 months were near the middle of the range of scores for this
measure but showed evidence of small differences between the
arms (table 2). Patient perception of their LUTS (measured using
the Brief Illness Perception Questionnaire) showed a greater
Table 4 | Expected adverse events identified from search of general practice electronic medical records
Adverse event Intervention arm
No of patients No of events per patient
Prostatitis 2 1 and 4
LUTS related urinary tract 2 3 and 2
infection
Urinary retention 1 1
Catheterisation 0 —
Death 2 —
LUTS=lower urinary tract symptoms.
Subgroup analyses
No effect modification was found when including the ratio of storage
to voiding LUTS at baseline as a continuous interaction term in the
model of IPSS at 12 months (P=0.971). Similarly, distinguishing
between those men who received the intervention via a study nurse
(n=249) or a practice nurse or healthcare assistant (n=190) also
showed no evidence of difference (P=0.387). Weak evidence of effect
modification (P=0.094) was, however, found in relation to how
intervention participants preferred follow-up by the clinical team
(telephone=310; text or email=121), with those opting for contact
by text or email showing a greater improvement than usual care.
Intervention delivery
Almost all the participants at intervention sites received the booklet
(98.5%) and 91.7% received all three planned follow-up contacts,
with most (79.0%) received in the protocolised format (week 1 by
telephone, weeks 4 and 12 as preferred by participants). Given the
high level of fidelity to the intervention, numbers deviating from
protocolised follow-up were small and thus the planned per protocol
analyses were underpowered, although findings were consistent
with a greater change in IPSS at 12 months in the intervention arm
(supplementary table S2). As only nine participants in the
intervention arm were deemed to have been non-adherent, the
planned complier average causal analysis was not performed.
Discussion
This large, pragmatic randomised controlled trial in primary care
showed that a range of bothersome LUTS improved over 12 months
in men with mean IPSS scores regarded as reflecting moderate
severity LUTS, using a standardised booklet and manualised
approach to symptom management. The mean patient reported
12
improvement in the intervention arm compared with usual care
arm at both six and 12 months (table 2).
Similar proportions of men were referred to secondary care over the
following 12 months (intervention 7.3% (35/478); usual care 7.9%
(43/544)). After adjusting for randomisation variables and
pre-baseline referrals, a difference between the arms was not evident
(adjusted odds ratio 0.91 (95% confidence interval 0.51 to 1.62);
P=0.76; intraclass correlation 0.02 (95% confidence interval 0.001
to 0.41)).
A similar, small number of LUTS related adverse events and deaths
were reported in both arms (table 4). All serious adverse events that
occurred during the study were unrelated to the intervention, such
as those affecting a separate organ system (eg, bilateral epistaxis),
with the exception of five that were deemed unlikely to be related
to the intervention (see supplementary table S3).
Usual care arm
No of patients No of events per patient
2 1 and 6
3 1 each
2 2 and 4
0 —
1 —
primary outcome (IPSS) was 1.81 points lower in the intervention
arm than usual care arm. The secondary outcomes measured using
the International Consultation on Incontinence Questionnaire and
IPSS quality of life also showed improvement against usual care,
demonstrating the overall impact on LUTS through incontinence,
post-void dribble, and quality of life. In addition, participants’
perception of their LUTS improved over 12 months in the
intervention arm (measured using the Brief Illness Perception
Questionnaire. Referral rates to urology did not differ greatly
between the arms. Adverse events also did not differ greatly between
the arms.
The response rate of patients invited to participate in the study was
48%, which could be because those men who were historically
coded as having LUTS in primary care in the previous five years
were no longer experiencing bothersome symptoms, or that
inaccuracies were present in the coding. In addition, only a single
invitation was sent, with no reminder. Of those who responded,
73% were interested in taking part. Response rates were unrelated
to acceptability of the intervention as men were blinded to their
randomisation group until they had consented to the study, and
without sight of the intervention booklet.
The mean IPSS at baseline was 13.6/14.6 in the two randomised
groups, which is moderate by the accepted symptom severity
categories (scores 8-19). The TRIUMPH study accepted men who
were still experiencing any bothersome LUTS despite having
consulted their doctor in the previous five years. This included
storage or voiding LUTS, post-void dribble, and monosymptomatic
nocturia (a symptom that can be caused by a wide range of medical
conditions unrelated to the lower urinary tract).19 20 Achieving
improvement of symptoms in such a mixed population, using
assessments and guidance in the form of a booklet provided by
the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219

nurses or healthcare assistants, is challenging. The mean reduction
in IPSS was 1.81 points greater than that obtained with usual care
and was sustained for at least nine months beyond the final
healthcare professional input into the intervention. Hence a
considerable number of men saw improvement in symptoms at low
risk and with low requirement for doctor’s input.
The target reduction of 2.0 points on which TRIUMPH was powered
was less than the more generally used minimal clinically important
difference of 3.0 points for the IPSS,16 as the threshold change for
“slight improvement” in symptoms is affected by baseline IPSS.15
A minimal clinically important difference of 2.0 points is appropriate
where baseline IPSS is <20. The study pragmatically included LUTS
in all in its manifestations, potentially including men with just one
symptom requiring treatment (eg, nocturia). For such men, the
baseline IPSS could be as low as 2 (ie, nocturia twice nightly, the
severity of nocturia generally accepted as impairing quality of life).19
These men could see improved quality of life when the severity of
their nocturia was reduced to once nightly21 (ie, a reduction in IPSS
from 2 to 1).
The observed reduction of 1.81 (95% confidence interval −2.66 to
−0.95) was smaller than the predefined target reduction of 2.0 points,
thus the improvement in symptoms related to the intervention may
be small.10 The reduction in symptom score was relative to usual
care, where a small overall reduction in IPSS was also seen at a
year. By taking part in the study, participants in the usual care arm
completed patient reported outcomes, received newsletters, and
were potentially influenced to reflect on their LUTS, hence triggering
health seeking behaviour that could improve their symptoms. The
clinical importance of this result is potentially increased given that
this pragmatic study of a non-drug intervention was unselective of
type or severity of LUTS and was based in primary care. In addition,
the result was sustained, with an interval (minimum nine months)
between the end of input from a healthcare professional and
measurement of the primary outcome.
We did not identify other studies of similar size directed at this issue.
A non-randomised pilot study of men with uncomplicated LUTS in
secondary care gave access to an online self-management
programme in the intervention arm, versus usual care from a
urologist.22 No significant differences was found between cohorts
for the IPSS, and uptake of the intervention was only 53%. A
randomised trial determined the effects of a health education
strategy for older adults living at home, providing a booklet on five
common health problems, including LUTS,23 and found that the
health education strategy did not change visits to a doctor within
three months. Both these studies suggest primary care is the most
appropriate setting to support self-care in LUTS.
Post-void dribble affects about half of men,24 and incontinence
affects about one man in eight.25 These are bothersome symptoms,26
so they were included in the standardised booklet used in the
intervention. Neither symptom is captured by the IPSS, however,
and therefore we used the International Consultation on
Incontinence Questionnaire Urinary Incontinence-Short Form when
men were assessed by healthcare professionals, to indicate who
should be directed to the applicable sections of the booklet. At 12
months, the mean International Consultation on Incontinence
Questionnaire Urinary Incontinence-Short Form score was 3.7 in
the intervention arm and 4.5 in the usual care arm (out of a
maximum score of 12). This small difference is unlikely to be
clinically significant overall, but it does not exclude the possibility
that individuals may have obtained a useful benefit. Similar benefits
of likely low importance were observed for the IPSS quality of life
the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
RESEARCH
(difference of 0.34 at 12 months) and possibly also men’s perception
of their LUTS (difference of 4.78 at 12 months).
A strong focus on drug management of LUTS in men persists,27
perhaps encouraging clinicians to rely on drug use; however, men
have tended previously to express a preference for conservative and
less risky treatment for LUTS.28 The TRIUMPH study found that
symptomatic improvement of LUTS can be sustained in the medium
term using clear written materials. Key features were practical
relevant assessment, interpretation by a suitably trained healthcare
professional, focus on the most applicable elements for the
individual’s symptoms, and supportive follow-up. The type of
healthcare professional (nurse or healthcare assistant) undertaking
the assessment and intervention did not appear to affect outcomes.
Accordingly, the intervention appeared to be well suited to delivery
by either type of healthcare professional in clinical practice.
Strengths and limitations of this study
This was a large pragmatic randomised controlled trial conducted
in a range of general practices in two English regions. Recruitment
of practices and men was high, and delivery of the intervention was
successful, including follow-up contacts to 12 weeks. Follow-up
was timed to capture whether the impact of the intervention was
sustained, with low missing data for patient reported outcomes at
12 months.
Some considerations are needed in interpreting the findings. The
preference for conservative and less risky treatment for LUTS is
potentially affected by baseline symptom severity,29 and the study
randomised men to receive an intervention regardless of baseline
severity, provided they considered their symptoms to be bothersome.
The study could not distinguish which specific symptoms improved
the most. Nocturia was included, but it can also have multifactorial
bases driven by several medical influences,19 20 and a qualitative
exploration has been published finding that men who have long
term disruptive symptoms, perceive that the booklet content was
novel or worthwhile, and believe that self-management might help
were more receptive to the intervention.30 The study was not able
to distinguish which elements of the intervention are necessary for
its success—for example, whether reduced follow-up contacts would
have been sufficient. The predominance of participants of white
ethnicity in the study populations may restrict applicability,
particularly for other ethnic groups. This merits additional
evaluation.
Conclusions and future research
Guidelines recommend conservative management as the preferred
treatment for LUTS in men. The TRIUMPH study showed that a
standardised and manualised intervention achieved a sustained
reduction in LUTS (difference in mean IPSS at 12 months of −1.81),
which was less than the predefined target reduction of 2.0 points.
Future research will be directed at integrating the TRIUMPH
intervention into general practice infrastructure, adapting it for
patients with low literacy or whose first language is not English,
including training materials, approaches to interpretation, and
access to the standardised booklet. Potentially, many of the
symptoms managed in this way are also experienced by women,
raising the possibility of developing an equivalent standardised
and manualised approach to managing LUTS in female patients.
What is already known on this topic
• Assessment of LUTS in men and use of conservative treatments in
primary care are limited and variable
13
 RESEARCH
• Evidence that conservative treatments are effective for LUTS in men
are limited, despite being recommended in national guidelines
What this study adds
• This study developed a standardised and manualised intervention
that provided a practical resource to support symptom assessment
and conservative treatment for LUTS in men in primary care
• The intervention achieved a sustained reduction in LUTS in a UK
primary care setting (difference in mean International Prostate
Symptom Score of −1.81 at 12 months), which was less than the
predefined target reduction of 2.0 points
AUTHOR AFFILIATIONS
1 were collected and managed using REDCap hosted at the University of Bristol.
Department of Surgery and Cancer, Faculty of Medicine, Imperial College, Hammersmith
Hospital, London, UK
2 sites for their involvement, and the West of England and Wessex Clinical Research Networks for their
Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of
Bristol, Bristol, UK
3
Department of Nursing and Midwifery, Faculty of Health and Applied Sciences,
University of the West of England, Bristol, UK
4 took part in the study. All participants provided written, informed consent to take part before entering
School of Health Sciences, University of Southampton, Southampton, UK
5
Oxford Institute Nursing, Midwifery and Allied Health Research, Oxford Brookes
University, Oxford, UK
6 1
Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK
7 ance/cg97 (last accessed 29 Dec 2021).
Tyntesfield Medical Group, Brockway Medical Centre, Nailsea, Bristol, UK
8 with lower urinary tract symptoms: results from the SF-36. Urology 1995;45:-71.
NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston
NHS Foundation Trust and the University of Bristol, University Hospitals Bristol
Education Centre, Bristol, UK
9 Eur Urol 2015;67:-109. doi: 10.1016/j.eururo.2014.12.038 pmid: 25613154
Patient representative, UK
10
Centre of Academic Primary Care, Population Health Sciences, Bristol Medical School,
University of Bristol, Bristol, UK
11
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
Contributors: MJD was the chief investigator of TRIUMPH; he conceived the study, participated in its
design and coordination, and drafted the manuscript. JAL, NC, MF, LM, HH, SJM, MJR, SN, JR, MJD, LAR,
and GT assisted with the study design. JW and JF developed the trial procedures, protocol, and
manuscript, and managed the coordination of the study. MM and JT assisted with the coordination of
the study. SJM designed the statistical analysis, and ES conducted the statistical analysis. MC contributed
to the data extraction from general practice medical records. All authors contributed to the oversight
of the study via the Trial Management Group, read and commented on drafts of the manuscript, and
approved the final version. MJD is the guarantor. The corresponding author attests that all listed authors
meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: This study was funded by the National Institute for Health and Care Research (NIHR, formerly
the National Institute of Health Research), Health Technology Assessment programme (No 16/90/03).
The views expressed in this publication are those of the authors and not necessarily those of the
National Health Service, NIHR or Department of Health and Social Care. MJR was partially funded by
a postdoctoral research fellowship from the NIHR (PDF-2014-07-013) from the start of the study until
31 December 2019. The funder had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript;
and decision to submit the manuscript for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/dis-
closure-of-interest/ and declare: support from the UK National Institute for Health and Care Research
Health Technology Assessment (HTA) programme for the submitted work; MJD reports personal fees
from Astellas and Pfizer, outside the submitted work. JR is chair of the Primary Care Urology Society,
which has received non-promotional sponsorship for annual meetings from Ferring, Astellas, Neotract,
and IMedicare. He has also received speaker fees from Astellas Pharmaceuticals. HH reports personal
fees from Medtronic, Astellas, Allergan, and Boston Scientific, outside the submitted work. JAL reports
receiving funding for the clinical trials unit (CTU) of which she was codirector, and she was a member
on the National Institute for Health and Care Research (NIHR) CTU Standing Advisory Committee. MJR
has been on several NIHR committees, including the Systematic Reviews NIHR Cochrane Incentive
Awards, HTA General Committee, Evidence Synthesis Programme Grants Committee, and NIHR Incentive
Awards Committee, and is currently on the Evidence Synthesis Programme Advisory Group. SJM is an
active member of the HTA General Committee.
14
The lead author (MJD) affirms that this manuscript is an honest, accurate, and transparent account of
the trial being reported; that no important aspects of the trial have been omitted; and that any
discrepancies from the trial as planned (and, if relevant, registered) have been explained.
Dissemination to participants and related patient and public communities: Participants of the TRIUMPH
study will be informed of the results through its website (bristol.ac.uk/triumph-study) and will be sent
details of the results in a study newsletter. Findings will also be disseminated through the media.
Provenance and peer review: Not commissioned; externally peer reviewed.
This study was registered prospectively (12 April 2018) before enrolment of the first participant. It was
designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK
Clinical Research Collaboration registered clinical trials unit which, as part of the Bristol Trials Centre,
was in receipt of Clinical Trials Unit support funding from the National Institute for Health and Care
Research (NIHR). The University of Bristol acted as the sponsor for this trial and the trial was hosted
by the NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group. The
TRIUMPH research team acknowledges the support of the NIHR Clinical Research Network. Study data
We thank all participants and the principal investigators and their teams at each of the TRIUMPH study
role in the study. We also thank the members of the Patient Advisory Group, Trial Steering Committee,
and Data Monitoring Committee.
Ethical approval: This study was approved by the National Research Ethics Service North West Preston
Ethics Committee (18/NW/0135) on 11 April 2018 and applied to all National Health Service sites that
the study.
Data sharing: All data requests should be submitted to the corresponding author for consideration.
Access to anonymised data may be granted following review.
NICE. The management of lower urinary tract symptoms in men: National Clinical Guideline
Centre; 2010; Last Updated 2015. Clinical Guideline 97. 2015. https://www.nice.org.uk/guid-
2 Hunter DJ, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men
doi: 10.1016/S0090-4295(99)80116-2 pmid: 7539561
3 Gratzke C, Bachmann A, Descazeaud A, etal. EAU Guidelines on the Assessment of
Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction.
4 Gibson W, Harari D, Husk J, Lowe D, Wagg A. A national benchmark for the initial assessment
of men with LUTS: data from the 2010 Royal College of Physicians National Audit of Continence
Care. World J Urol 2016;34:-77. doi: 10.1007/s00345-015-1702-5 pmid: 26466843
5 Oelke M, Bachmann A, Descazeaud A, etalEuropean Association of Urology. EAU guidelines on
the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including
benign prostatic obstruction. Eur Urol 2013;64:-40.
doi: 10.1016/j.eururo.2013.03.004 pmid: 23541338
6 NICE. Lower urinary tract symptoms: Evidence Update March 2012. National Institute for Health
and Care Excellence. NICE, 2012.
7 Yap TL, Brown C, Cromwell DA, van der Meulen J, Emberton M. The impact of self-management
of lower urinary tract symptoms on frequency-volume chart measures. BJU Int 2009;104:-8.
doi: 10.1111/j.1464-410X.2009.08497.x pmid: 19485993
8 Brown CT, Yap T, Cromwell DA, etal. Self management for men with lower urinary tract symptoms:
randomised controlled trial. BMJ 2007;334:. doi: 10.1136/bmj.39010.551319.AE pmid: 17118949
9 Frost J, Lane JA, Cotterill N, etal. TReatIng Urinary symptoms in Men in Primary Healthcare using
non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study
protocol for a cluster randomised controlled trial. Trials 2019;20:.
doi: 10.1186/s13063-019-3648-1 pmid: 31477160
10 Macneill SJ, Drake MJ. TRIUMPH: TReatIng Urinary symptoms in Men in Primary Healthcare using
non-pharmacological and non-surgical intervention https://research-information.bris.ac.uk/ws/por-
talfiles/portal/248729952/TRIUMPH_SAP_v1_2_45_1_.pdf 31 Jul 2020.
11 Barry MJ, Fowler FJ, JrO’Leary MP, etalThe Measurement Committee of the American Urological
Association. The American Urological Association symptom index for benign prostatic hyperplasia.
J Urol 1992;148:-57, discussion 1564. doi: 10.1016/S0022-5347(17)36966-5 pmid: 1279218
12 Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure
for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23:-30.
doi: 10.1002/nau.20041 pmid: 15227649
13 Herdman M, Gudex C, Lloyd A, etal. Development and preliminary testing of the new five-level
version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:-36.
doi: 10.1007/s11136-011-9903-x pmid: 21479777
14 Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom
Res 2006;60:-7. doi: 10.1016/j.jpsychores.2005.10.020 pmid: 16731240
15 Barry MJ, Williford WO, Chang Y, etal. Benign prostatic hyperplasia specific health status measures
in clinical research: how much change in the American Urological Association symptom index
and the benign prostatic hyperplasia impact index is perceptible to patients?J Urol 1995;154:-4.
doi: 10.1016/S0022-5347(01)66780-6 pmid: 7563343
the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219
 RESEARCH

16 Barry MJ, Cantor A, Roehrborn CGCAMUS Study Group. Relationships among participant
international prostate symptom score, benign prostatic hyperplasia impact index changes and
global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J
Urol 2013;189:-92. doi: 10.1016/j.juro.2012.08.257 pmid: 23017510
17 Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient
in cluster randomized trials: the case of implementation research. Clin Trials 2005;2:-107.
doi: 10.1191/1740774505cn071oa pmid: 16279131
18 Griffin T, Peters TJ, Sharp D, Salisbury C, Purdy S. Validation of an improved area-based method
of calculating general practice-level deprivation. J Clin Epidemiol 2010;63:-51.
doi: 10.1016/j.jclinepi.2009.07.019 pmid: 19914798
19 Marshall SD, Raskolnikov D, Blanker MH, etalInternational Consultations on Urological Diseases.
Nocturia: Current Levels of Evidence and Recommendations From the International Consultation
on Male Lower Urinary Tract Symptoms. Urology 2015;85:-9.
doi: 10.1016/j.urology.2015.02.043 pmid: 25881866
20 Smith M, Dawson S, Andrews RC, etal. Evaluation and Treatment in Urology for Nocturia Caused
by Nonurological Mechanisms: Guidance from the PLANET Study. Eur Urol Focus 2022;8:-97.
doi: 10.1016/j.euf.2022.01.007 pmid: 35101453
21 Weiss JP, Zinner NR, Klein BM, Nørgaard JP. Desmopressin orally disintegrating tablet effectively
reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn
2012;31:-7. doi: 10.1002/nau.22243 pmid: 22447415
22 Blanker MH, Admiraal A, Brandenbarg P, etal. Effectiveness of a newly developed online
self-management program for male patients with uncomplicated lower urinary tract symptoms.
Neurourol Urodyn 2019;38:-9. doi: 10.1002/nau.24131 pmid: 31385388
23 van Eijken M, Wensing M, de Konink M, etal. Health education on self-management and seeking
health care in older adults: a randomised trial. Patient Educ Couns 2004;55:-54.
doi: 10.1016/j.pec.2003.07.004 pmid: 15476989
24 Pöyhönen A, Auvinen A, Koskimäki J, Hakama M, Tammela TL, Häkkinen JT. Prevalence and
bother of postmicturition dribble in Finnish men aged 30-80 years: Tampere Ageing Male Urologic
Study (TAMUS). Scand J Urol Nephrol 2012;46:-23.
doi: 10.3109/00365599.2012.702786 pmid: 22835055
25 Diokno AC, Estanol MV, Ibrahim IA, Balasubramaniam M. Prevalence of urinary incontinence in
community dwelling men: a cross sectional nationwide epidemiological survey. Int Urol Nephrol
2007;39:-36. doi: 10.1007/s11255-006-9127-0 pmid: 17086446
26 Ito H, Young GJ, Lewis AL, etal. Grading Severity and Bother Using the International Prostate
Symptom Score and International Consultation on Incontinence Questionnaire Male Lower Urinary
Tract Symptoms Score in Men Seeking Lower Urinary Tract Symptoms Therapy. J Urol
2020;204:-11. doi: 10.1097/JU.0000000000001149 pmid: 32469267
27 Soler R, Andersson KE, Chancellor MB, etal. Future direction in pharmacotherapy for
non-neurogenic male lower urinary tract symptoms. Eur Urol 2013;64:-21.
doi: 10.1016/j.eururo.2013.04.042 pmid: 23711541
28 Malde S, Umbach R, Wheeler JR, etal. A Systematic Review of Patients’ Values, Preferences, and
Expectations for the Diagnosis and Treatment of Male Lower Urinary Tract Symptoms. Eur Urol
2021;79:-809. doi: 10.1016/j.eururo.2020.12.019 pmid: 33461781
29 Malde S, Umbach R, Wheeler JR, etal. A Systematic Review of Patients’ Values, Preferences, and
Expectations for the Diagnosis and Treatment of Male Lower Urinary Tract Symptoms. Eur Urol
2021;79:-809. doi: 10.1016/j.eururo.2020.12.019 pmid: 33461781
30 Olaniyi P, Cotterill N, Drake MJ, etal. Qualitative Assessment of the Conservative Management
of Nocturia with Standardised Written Materials for Lower Urinary Tract Symptoms in Men Treated
in Primary Care. Eur Urol Focus 2022;8:-80. doi: 10.1016/j.euf.2022.01.003 pmid: 35034867

Supplementary information: Additional tables S1-S3

Supplementary information: Administration checklist for study
booklet
Supplementary information: Intervention booklet: Helping you
control your waterworks

This is an Open Access article distributed in accordance with the terms of the Creative Commons
Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this
work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/li-
censes/by/4.0/.

the bmj | BMJ 2023;383:e075219 | doi: 10.1136/bmj-2023-075219 15